Costs of musculoskeletal conditions represent an average of 3% of the gross domestic product of developed countries, which consumes an estimated $254 billion annually in the U.S. In addition, the U.S. market segment for orthopedic implants is around $100 million and growing.
Regeneration of natural skeletal tissue represents a promising new approach to expand the range of conditions that can be effectively treated. Investigators have developed various biomaterial-based approaches to direct bone regeneration. However, shortcomings concerning the creation of new tissue regeneration approaches have slowed translation of new technologies from the laboratory to the clinic.
Regeneration of skeletal tissues is an active area of study in academia and industry. Revenues for bone growth therapeutic products are expected to grow by more than 40% per year for the foreseeable future. (Medtech Insight, “Poor man's growth factors: do they work?,” Medtech Insight Newsletter, November/December 2003:263-264).
Costs for musculoskeletal conditions may represent an average of 3% of the GDP of some developed countries, which may consume an estimated $254 billion annually. For example, in the U.S. bone and joint disease account for half of all chronic conditions in people over the age of 50. (Knowledge Enterprise, “the worldwide orthopedic market,” The Institute for Orthopedic Enlightenment, Chagrin Falls, Ohio, 2003:1-60). This age group may also double in population by 2020, which suggests a tremendous rapidly growing need for new and effective bone repair/replacement therapies.
Such new and effective therapies (designed to induce bone regeneration in skeletal defects or injuries) have been limited by the need for efficient and effective targeted and controlled delivery of therapeutic drug molecules locally within the body. Compatibility with conventional standard surgical techniques and procedures has also limited implementation of various therapies.
Various “inductive” molecules are able to stimulate bone regeneration, however, efficient targeted and controlled delivery of such therapeutic inductive molecules remains problematic. Others have reported development of a gas foaming polymer process providing fabrication of three-dimensional porous matrices from bioabsorbable materials, whereby angiogenic factors were subsequently incorporated into the matrices during the fabrication process, and the angiogenic factors are released in a controlled manner. (Sheridan M, et al., “Bioabsorbable polymer scaffolds for tissue engineering capable of sustained growth factor delivery,” J. Control. Release 2000, 64:94-102).
There still exists a need to provide drug delivery platforms, dosage forms, compositions, methods and devices thereof capable of delivering inductive molecules in a targeted and controlled fashion having suitable bioavailability.
In addition, use of new tissue regeneration approaches by clinicians has been troublesome because they are often not designed for facile translation into existing surgical procedures, which renders such approaches impractical.
The instant invention advantageously overcomes the problems and needs set forth herein.